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Ibrutinib

  1. Iziyobisi ekujoliswe kuzo Ibrutinib (CAS: 936563-96-1)
  2. Inkqubo yeIbrutinib yokuSebenza
  3. Isetyenziselwa ntoni i-Ibrutinib
  4. Izibonelelo zeIbrutinib / Iziphumo
  5. Sifanele njani ukuba siyithathe i-Ibrutinib
  6. Iziphumo ebezingalindelekanga ze-Ibrutinib
  7. Ukugcinwa kweIbrutinib

Iziyobisi ekujoliswe kuzo Ibrutinib(ICAS: 936563-96-1)

Unyango oluninzi olutsha lwe-lymphoma lujolise kwiziyobisi. Iziyobisi ekujoliswe kuzo zijolise ekubulaleni uhlobo lweseli oluye lwajika lwaba ngumhlaza okanye ukumisa imiqondiso eyenza ukuba iiseli ezinomhlaza zikhule okanye zahlule. Kwi-lymphoma, uhlobo lweseli oluba ngumhlaza lubizwa ngokuba yi "lymphocyte" (uhlobo lweseli emhlophe yegazi elwa nosulelo). Kukho iintlobo ezininzi ze-lymphocyte ezinokuba ngumhlaza. Ibrutinib ijolise kwii-lymphocyte B (iiseli ze-B) kwaye ke isetyenziselwa ukunyanga i-B-cell lymphomas.

Iiseli zithumela kwaye zifumane imiqondiso kwezinye iiseli. Eminye yale miqondiso igcina iiseli ziphila kwaye zibenza bohlule. Zininzi iindlela zokubonisa kwaye imiqondiso ithunyelwa ecaleni kwelinye okanye nangaphezulu kwezi ndlela. Ibrutinib sisithinteli somqondiso weseli ejolise kwiprotein ebizwa ngokuba yi 'Bruton' s tyrosine kinase '(BTK). I-BTK yinxalenye yendlela enceda iiseli ze-B ukuba zihlale ziphila zize zahlule. Ukuthintela i-BTK kunokwenza iiseli ze-B zife okanye zibathintele ekwahlukaneni. Olu nyango lunokumisa ukunwenwa kweeseli zomhlaza ze-B.

 

Ibrutinib Indlela yokuSebenza

Ibrutinib (936563-96-1) asiyoyeza lokunyanga ngamachiza kodwa yenye yezo kuthiwa “zizonyango ekujoliswe kuzo.” Unyango ekujoliswe kulo sisiphumo seminyaka yophando enikezelwe ekuqondeni umahluko phakathi kweeseli zomhlaza kunye neeseli eziqhelekileyo. Ukuza kuthi ga ngoku, unyango lomhlaza lujolise ikakhulu ekubulaleni iiseli ezahlula ngokukhawuleza kuba inqaku elinye leseli zomhlaza kukuba zahlule ngokukhawuleza. Ngelishwa, ezinye zeeseli zethu eziqhelekileyo zahlula ngokukhawuleza nazo, zibangela iziphumo ebezingalindelekanga ezininzi.

Ulwaphulo olujoliswe kulo lu malunga nokuchonga ezinye iimpawu zeseli zomhlaza. Iingcali zenzululwazi zikhangelelanisa iimeko ezahlukeneyo kumaseli omhlaza kunye neeseli eziqhelekileyo. Le ngcaciso isetyenziselwa ukudala unyango olujoliswe ekuhlaseleni amangqamuzana omhlaza ngaphandle kokulimaza iiseli eziqhelekileyo, ngaloo ndlela zikhokelela kwimiphumo emibini yecala. Uhlobo ngalunye lonyango olujoliswe kuyo lusebenza kancinci kodwa lugxininise ukukwazi ukukhula, ukwahlula, ukulungiswa kunye / okanye ukunxibelelana namanye amaseli.

Ibrutinib inqanda ukusebenza kweBruton's tyrosine kinase (BTK). I-BTK yimolekyuli ephambili yokubonisa i-B-cell receptor signaling complex edlala indima ebalulekileyo ekusindeni kweeseli ze-B ezimbi. Ibrutinib ibhloka imiqondiso evuselela iiseli ezinobungozi ukuba zikhule kwaye zahlule ngokungalawulekiyo. Uphando luyaqhubeka nokuchonga ukuba yeyiphi na imihlaza enokuthi inyangwe kakuhle ngonyango ekujoliswe kulo kunye nokuchonga iithagethi ezongezelelweyo zeentlobo ezininzi zomhlaza.

Qaphela: Siyakukhuthaza ngamandla ukuba uthethe noononophelo lwempilo yakho malunga nemeko ethile yonyango kunye nonyango. Ulwazi oluqulethwe kule webhusayithi yenzelwe ukuba luncedo kwaye ifundise, kodwa ayithathi ndawo iingcebiso zonyango.

I-AASraw ngumenzi wobugcisa we-Ibrutinib.

Nceda ucofe apha ngolwazi locaphulo: Unxibelelwano nathi

 

Isetyenziselwa ntoni i-Ibrutinib

❶ Ukunyanga abantu abane-mantle cell lymphoma (i-MCL; umhlaza okhula ngokukhawuleza oqala kwiiseli zamasosha amajoni omzimba) esele zinyangwe okungenani ngamanye amayeza e-chemotherapy.

❷ Ukunyanga abantu nge Leukemia engapheliyo ye-lymphocytic (CLL; uhlobo lomhlaza oqala kwiiseli ezimhlophe zegazi) kunye ne-lymphocytic lymphoma (SLL; uhlobo lomhlaza oqala ikakhulu kwii-lymph node).

❸ Ukunyanga abantu abaneWaldenstrom's macroglobulinemia (WM; umhlaza okhula kancinci oqala kwiiseli ezithile ezimhlophe zomongo wethambo).

❹ Ukunyanga abantu abane-lymphoma zone marginal (MZL; umhlaza okhula kancinci oqala kuhlobo lweeseli ezimhlophe zegazi ezihlala zilwa nosulelo) esele liphathwe ngohlobo oluthile lwamayeza e-chemotherapy.

❺ Ukunyanga abantu abanesifo esinganyangekiyo sokudityaniswa kwentsholongwane (i-cGVHD; ingxaki ye-hematopoietic stem-cell transplant [HSCT; inkqubo ethatha indawo yomongo wethambo onesifo kunye nomongo wethambo osempilweni] enokuthi iqale okwethutyana emva kokufakelwa kwaye ihlale ixesha elide ) emva kokuphathwa ngokungaphumeleli nge-1 okanye ngaphezulu amayeza.

Ibrutinib ikwiklasi yamayeza abizwa ngokuba yi-kinase inhibitors. Isebenza ngokuthintela isenzo seproteyini engaqhelekanga ebonisa iiseli zomhlaza ukuba zande. Oku kunceda ukunqanda ukusasazeka kweeseli zomhlaza.

Ibrutinib

Ibrutinib benefits/ Iziphumo

Ibrutinib ithathwa njengeengcali ezininzi ukuba zibe 'lonyango lokuphumelela' kwezinye iintlobo ze-lymphoma. Inika amaqondo okuphendula aphezulu xa kuthelekiswa nezinye iindlela zonyango kwiindidi ezifanayo ze-lymphoma. Izilingo eziphambili ezikhokelele ekuvunyelweni kwe-ibrutinib zichazwe ngokufutshane apha ngezantsi.

 

(1) Izibonelelo ngengubo yeseli lymphoma

I-Mantle cell lymphoma ebuyile okanye engaphendulanga kunyango lokuqala kunokuba nzima ukuyinyanga. Nangona kunjalo, uphononongo oluphambili kule ndawo lubonise ukuba ngaphezulu kwesibini kwisithathu sabantu abali-111 abaphathwe nge-ibrutinib baphendule kunyango (i-lymphoma shrank okanye yanyamalala).

Isifundo sesibini kubantu abangama-280 bafanisa ibrutinib kunye nesinye isiyobisi somhlaza, i-temsirolimus, kubantu ababuyile okanye abachasayo ngengubo yeseli lymphoma. Abantu baphila i-avareji yeenyanga ezili-15 ngaphandle kokuba i-lymphoma yabo isiba mandundu xa bephathwa nge-ibrutinib xa kuthelekiswa ne-avareji yeenyanga ezi-6 xa bephathwa nge-temsirolimus.

 

(2) Izibonelelo kwi-lymphocytic leukemia (CLL)

Iimpendulo ezihlala ixesha elide zibonwe kubantu abane-CLL baphathwa nge-ibrutinib. Kwilingo eliphambili elibandakanya abantu abangama-391 abane-CLL ebuyela umva okanye enqabileyo, ibrutinib yafaniswa ne-ofatumumab, ehlala isetyenziselwa abantu abane-CLL ababuyileyo. Kunyaka omnye emva kokuqala unyango, malunga nama-66 kubantu abali-100 abathatha ibrutinib babene-CLL eyayihleli iphantsi kolawulo (oku kubizwa ngokuba 'kukuqhubeka ngaphandle kokuqhubela phambili') xa kuthelekiswa nabantu abayi-6 kwabali-100 abaphathwe nge-ofatumumab.

Kwisifundo sesibini esibandakanya abantu abangama-269 ababengekafumani nonyango lwe-CLL yabo, ibrutinib yafaniswa ne-chemotherapy drug chlorambucil. Emva kweminyaka eyi-1.5 yonyango, malunga ne-90 kwi-100 yabantu abathatha i-ibrutinib babene-CLL eyayihleli iphantsi kolawulo xa kuthelekiswa nabantu abangama-52 kwabali-100 abaphathwa nge-chlorambucil.

Ukongeza ibrutinib kwi-bendamustine kunye ne-rituximab yabantu abane-CLL ebuyileyo okanye enqabileyo yayisebenza kwisifundo esibandakanya abantu abangama-578. Umngcipheko wokuqhubela phambili kwe-CLL wancitshiswa ngokuthatha ibrutinib endaweni ye-placebo (unyango lwedummy).

 

(3) Izibonelelo eWaldenström' s macroglobulinaemia (WM)

Izinga eliphezulu lokuphendula liye labonwa kubantu abane-WM-malunga ne-9 kwabali-10 abantu abane-WM abaphendulayo Unyango lwe-ibrutinib kwityala kubantu abangama-63. Oluvavanyo lwaluyinkqubela ebonakalayo kwi-WM njengoko iyindlela engaqhelekanga ye-lymphoma kwaye ke kunzima ukufumana abantu abaneleyo ukuba bathathe inxaxheba kuvavanyo lweklinikhi. Eli tyala lakhokelela ekuvunyweni kwe-ibrutinib ye-WM eYurophu.

 

Sifanele ukuthatha njani Ibrutinib 

Uya kunikwa ibrutinib njengeepilisi. Inokunikwa ngokudibeneyo nezinye iziyobisi zonyango ekujoliswe kuzo kunye ne-chemotherapy. Ngexesha lonyango uhlala ubona ugqirha we-cance¬r, umongikazi onomhlaza okanye umongikazi oyingcali, kunye nosokhemesti oyingcali. Nguye lo sithetha ngaye xa sikhankanya ugqirha, umongikazi okanye usokhemesti kolu lwazi.

Phambi okanye ngosuku lonyango, umongikazi okanye umntu oqeqeshelwe ukuthatha igazi (phlebotomist) uyakuthatha isampulu yegazi kuwe. Oku kukujonga ukuba iiseli zakho zegazi zikwinqanaba elikhuselekileyo ukuze ufumane unyango.

Uya kubona ugqirha okanye umongikazi ngaphambi kokuba ufumane unyango. Baza kukubuza ukuba uziva njani. Ukuba iziphumo zakho zegazi zilungile, usokhemisti uya kulungiselela unyango lwakho. Umongikazi wakho uza kukuxelela xa kunokwenzeka ukuba unyango lwakho lukulungele.

Umongikazi okanye usokhemesti uya kukunika iipilisi ze-ibrutinib zokugoduka nazo. Soloko ubathatha ngokuchanekileyo njengoko kuchaziwe. Oku kubalulekile ukuqinisekisa ukuba basebenza kangangoko kunokwenzeka kuwe. Unokunikwa iipilisi zamandla ahlukeneyo. Uhlala ugcina ukuthatha ibrutinib yonke imihla okoko igcina umhlaza phantsi kolawulo. Umongikazi wakho okanye usokhemesti unokukunika neziyobisi ezichasene nokugula kunye namanye amayeza oza nawo ekhaya. Thatha onke amacwecwe akho njengoko kuchaziwe kuwe.

I-AASraw ngumenzi wobugcisa we-Ibrutinib.

Nceda ucofe apha ngolwazi locaphulo: Unxibelelwano nathi

 

Isikhumbuzo eshushu ekuzinyamekeleni

Ngelixa uthatha ibrutinib, sela ubuncinci i-quits ezimbini zolwelo qho kwiiyure ezingama-24, ngaphandle kokuba uyalelwe ngenye indlela.

Hlamba izandla zakho rhoqo nasemva kokuthatha idosi nganye ye-ibrutinib.

Be Unokuba semngciphekweni wokosuleleka ke zama ukuphepha izihlwele okanye abantu abanemikhuhlane, kwaye uxele umkhuhlane okanye naziphi na ezinye iimpawu zosulelo kwangoko kumboneleli wakho wezempilo.

Ukunceda ukunyanga / ukuthintela izilonda zomlomo ngelixa uthatha ibrutinib, sebenzisa ibrashi yamazinyo ethambileyo, kwaye uhlambe kathathu ngemini ngepunipoyi ye-1 yesoda exutywe nee-ounces ezi-8 zamanzi.

Sebenzisa isitshetshe sombane kunye nebrashi yamazinyo ethambileyo ukunciphisa ukopha.

Kulumkele ukunxibelelana nemidlalo okanye izinto ezinokubangela ukwenzakala.

♦ Ukunciphisa isicaphucaphu, thatha amayeza okunyanga isicaphucaphu njengoko kumiselwe ngugqirha wakho, kwaye utye ukutya okuncinci, okuncinci rhoqo ngelixa uthatha ibrutinib.

Yitya ukutya okunokunceda ukunciphisa urhudo-jonga Ukulawula iziphumo ebezingalindelekanga- Urhudo

Landela irejimeni yamayeza alwa norhudo njengoko kumiselwe yingcali yezempilo.

♦ Kuphephe ukubekwa elangeni. Gqoka i-SPF 15 (okanye ngaphezulu) ibhloko yelanga kunye nempahla yokukhusela. Ibrutinib inokukwenza ube nolwazelelelo ngakumbi elangeni kwaye unokutshiswa lilanga ngokulula.

Ngokubanzi, ukusela iziselo ezinxilisayo kufuneka kugcinwe ubuncinci okanye kuthintelwe ngokupheleleyo ngelixa uthatha ibrutinib. Kuya kufuneka uxoxe ngale nto nogqirha wakho.

Phumla ngokwaneleyo.

Gcina ukutya okunesondlo ngelixa unyangwa nge-ibrutinib.

You Ukuba ufumana iimpawu okanye iziphumo ebezingalindelekanga ngelixa unyangwa nge-ibrutinib, qiniseka ukuba uxoxa ngazo neqela lakho lokhathalelo lwempilo. Banokuyalela amayeza kunye / okanye banikeze ezinye iingcebiso ezifanelekileyo ekulawuleni ezo ngxaki.

 

Ibrutinib SIDE Eiimpembelelo

Fumana uncedo lwezonyango loxakeka xa unemiqondiso yokumelana nomonakalo: imihlathi; ukuphefumula okunzima; ukuvuvukala kobuso bakho, imilomo, ulwimi, okanye umqala.

 

Yeka ukusebenzisa ibrutinib kwaye ubize ugqirha wakho kwangoko ukuba unayo:

Of Iimpawu zosulelo- umkhuhlane, Ukugodola, ubuthathaka, izilonda zomlomo, ukukhohlela ngefinyila, ukungaphefumli kakuhle;

Iimpawu zokopha ngaphakathi emzimbeni-isiyezi, ubuthathaka, ukudideka, iingxaki ekuthetheni, intloko ebuhlungu ixesha elide, isitulo esimnyama okanye esinegazi, umchamo opinki okanye omdaka, okanye ukukhohlela igazi okanye ukugabha okungathi yindawo yekofu;

Di Urhudo oluqatha okanye oluqhubekayo;

Intlungu yesifuba, ukubetha kwentliziyo okanye ukubetha esifubeni sakho, uziva ngathi ungaphuma;

Headache Intloko ebuhlungu, ukungaboni kakuhle, ukubetha entanyeni okanye ezindlebeni;

Ukutyumka ngokulula, ukopha okungaqhelekanga, amabala emfusa okanye abomvu phantsi kolusu lwakho;

Skin Isikhumba esimdaka, izandla ezibandayo neenyawo;

Iingxaki zezintso –ukuchama kancinci okanye ungabikho kwaphela, ukudumba iinyawo zakho okanye amaqatha; okanye

Of Iimpawu zokuqhekeka kweseli ithumba- ukudideka, ukuba buthathaka, izihlunu zemithambo, isicaphucaphu, ukugabha, ukukhawulezisa okanye ukubetha kwentliziyo kancinci, ukuncipha kokuchama, ukubetha ezandleni nasezinyaweni okanye emlonyeni.

 

Iziphumo eziqhelekileyo ziquka:

♦ Urhudo, isicaphucaphu;

Umkhuhlane, ukukhohlela, ukuphefumla nzima;

Amadyungudyungu okanye izilonda emlonyeni wakho;

Tired Ndiziva ndidiniwe;

Ru ukukrala, irhashalala; okanye

Pain Intlungu yezihlunu, iintlungu zethambo.

Oku akusiyo uluhlu olupheleleyo lweempembelelo kwaye abanye bangenzeka. Shayela ugqirha wakho kwiingcebiso zonyango malunga nemiphumo emibi. Ungabika iziphumo ezimbi kwi-FDA kwi-1-800-FDA-1088.

I-AASraw ngumenzi wobugcisa we-Ibrutinib.

Nceda ucofe apha ngolwazi locaphulo: Unxibelelwano nathi

 

Ibrutinib Sisibetho

Gcina i-Ibrutinib kwisitya esangena, ivaliwe ngokuqinileyo, kwaye ayifumaneki ebantwaneni. Yigcine kubushushu begumbi kwaye kude nokukhanya, ubushushu obugqithisileyo kunye nokufuma hayi kwigumbi lokuhlambela.

Ibrutinib engafunekiyo kufuneka ilahlwe ngeendlela ezizodwa zokuqinisekisa ukuba izilwanyana zasekhaya, abantwana kunye nabanye abantu abanakuzitya. Nangona kunjalo, awufanele uyigungxule le Ibrutinib ezantsi kwindlu yangasese. Endaweni yoko, eyona ndlela yokulahla amayeza akho yinkqubo yokubuyisa amayeza. Thetha kumachiza wakho okanye unxibelelane nesebe lakho lenkunkuma / lokurisayikilisha ukuze ufunde malunga neenkqubo zokubuyisa kwindawo ohlala kuyo. Jonga ukulahlwa ngokukhuselekileyo kwe-FDA

Kubalulekile ukugcina onke amayeza angabonakaliyo kunye nokufikelela kubantwana njengezikhonkwane ezininzi (ezifana neepilisi zeveki zeeveki kunye nezokwamahla, i-creams, i-patches, kunye ne-inhalers) abaxhomeki abantwana kunye nabantwana abancinci bangabavula ngokulula. Ukukhusela abantwana abancinci besetyhefu, soloko uvale iifake zokuphepha kwaye ubeke ngokukhawuleza loo mayeza kwindawo ekhuselekileyo - enye ephakanyisiwe kwaye ingabikho emehlweni abo kwaye ifinyelele.

 

isingqiniso

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[2] Ngu-Byrd JC, Brown JR, O'Brien S, et al; BONELELE Abaphandi. Ibrutinib xa ithelekiswa ne -atumumab kunyango lwe-lymphoid leukemia. N Engl J Med. Ngo-2014; 371 (3): 213-223.

[3] U-Byrd JC, uFurman RR, uCoutre SE, et al. Ukuchaneka Ukulandelwa kweminyaka emithathu yonyango-naïve kunye nezigulana ezanyangwa ngaphambili ezine-CLL kunye ne-SLL ifumana iarhente enye ibrutinib. Igazi. Ngo-2015; 125 (16): 2497-2506.

[4] Mato AR, Hill BT, Lamanna N, okqhubekayo. Ukulandelelana ngokuchanekileyo kwe-ibrutinib, idelalisib, kunye ne-venetoclax kwi-lempemia ye-lymphocytic engapheliyo: iziphumo ezivela kwizifundo ezininzi zezigulana ezingama-683. UAnn Oncol. Ngo-2017; 28 (5): 1050-1056.

[5] UWoyach JA, uRuppert AS, uGuinn D, et al. I-BTKC481S-ukumelana okuchasene ne-ibrutinib kwi-leukemia engapheliyo ye-lymphocytic. J Ikliniki ye-Oncol. Ngo-2017; 35 (13): 1437-1443.

[6] I-Winqvist M, i-Asklid A, kunye no-Andersson PO, et al. Iziphumo zehlabathi lokwenyani ze-ibrutinib kwizigulana ezibuyise umva okanye ezinqabileyo ezine-lymphocytic leukemia: idatha evela kwizigulana ezingama-95 ezilandelelanayo ziphathwa kwinkqubo yovelwano. Isifundo esivela kwiqela laseSweden leLymphocytic Leukemia Group. I-Haematologica. Ngo-2016; 101 (12): 1573-1580.

[7] UJones JA, uHillmen P, uCoutre S, et al. Ukusetyenziswa kwee-anticoagulants kunye ne-antiplatelet kwizigulana ezine-lymphocytic leukemia enganyangekiyo nge-arhente enye ibrutinib. UBr J Haematol. Ngo-2017; 178 (2): 286-291.

[8] UKamel S, uHorton L, uYsebaert L, et al. Ibrutinib inhibit collagen-Mediated kodwa hayi i-ADP-Mediated platelet aggregation. Ileukemia. 2015; 29 (4) 783-787.

[9] URigg RA, uAslan JE, uHealy LD, et al. Ulawulo lomlomo lweBruton's tyrosine kinase inhibitors lonakalisa umsebenzi weplatelet ye-GPVI. NdinguJ Physiol weSelfowuni. Ngo-2016; 310 (5): C373-C380.

[10] UWang ML, uMgaqo S, uMartin P, et al. Ukujolisa kwi-BTK kunye ne-ibrutinib kwi-mantle-cell lymphoma ebuyileyo okanye ephikisayo. N Engl J Med. Ngo-2013; 369 (6): 507-516.

[11] I-Treon SP, i-Tripsas CK, iMeid K, et al. U-Ibrutinib kwi-macroglobulinemia yeWaldenström ngaphambili. N Engl J Med. 2015; 372 (15): 1430-1440.

[12] ULampson BL, uYu L, uGlynn RJ, et al. I-Ventricular arrhythmias kunye nokufa ngesiquphe kwizigulana ezithatha ibrutinib. Igazi. Ngo-2017; 129 (18): 2581-2584.

[13] I-Tedeschi A, i-Frustaci AM, i-Mazzucchelli M, i-Cairoli R, i-Montillo M. Ngaba i-HBV prophylaxis iyadingeka ngexesha lonyango lwe-CLL nge-ibrutinib? ILeuk Lymphoma. Ngo-2017; 58 (12): 2966-2968.

[14] Ilanga C, Tian X, Lee YS, et al. Ukuphinda kusebenze kwakhona ukungasebenzi komzimba kunye nosulelo oluncinci kwizigulana ezine-lymphocytic leukemia enganyangekiyo nge-ibrutinib. Igazi. 2015; 126 (19): 2213-2219.

[15] URuchlemer R, uBen Ami R, uLakish T. Ibrutinib we-lymphocytic leukemia engapheliyo. N Engl J Med. Ngo-2016; 374 (16): 1593-1594.

[16] Ahn IE, Jerussi T, Farooqui M, Tian X, Wiestner A, Gea-Banacloche J. Igazi. Ngo-2016; 128 (15): 1940-1943.

[17] UVitale C, Ahn IE, uSivina M, et al. Ngokuzenzekelayo ii-cytopenias kwizigulana ezine-lymphocytic leukemia enganyangekiyo ephathwe nge-ibrutinib. I-Haematologica. Ngo-2016; 101 (6): e254-e258.

[18] Umlomo we-GY, uPan X, uKamble S, et al. Umngcipheko omkhulu wokopha phakathi kwezigulana ze-atrial fibrillation ezingezizo i-valvular eziqaliswe kwi-apixaban, dabigatran, rivaroxaban powder okanye warfarin: isifundo sehlabathi "sokwenyani" eUnited States. Int J Clin Ukuziqhelanisa. Ngo-2016; 70 (9): 752-763.

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